PULSION PICCO PLUS, MODEL 8100

K060898 · Pulsion Medical Systems AG · DXG · Jul 25, 2006 · Cardiovascular

Device Facts

• Record ID: K060898
• Device Name: PULSION PICCO PLUS, MODEL 8100
• Applicant: Pulsion Medical Systems AG
• Product Code: DXG · Cardiovascular
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The PULSION PiCCO Plus is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO Plus measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered. the PiCCO Plus presents the derived parameters indexed to body surface area.

Device Story

PiCCO Plus monitors hemodynamic status via pulse contour analysis and thermodilution. Inputs: arterial pressure waveform (via arterial catheter) and thermodilution data (via central venous and arterial thermistor catheters). Device processes signals to calculate cardiac output, heart rate, systolic/diastolic/mean arterial pressure, and fluid volumes (intravascular/extravascular). Used in clinical settings (e.g., ICU) by trained healthcare professionals. Output displayed on monitor for real-time hemodynamic assessment. Assists clinicians in fluid management and cardiovascular therapy decisions; benefits patient through precise monitoring of circulatory function.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications.

Technological Characteristics

Hemodynamic monitoring system utilizing pulse contour analysis and thermodilution. Interfaces with arterial and central venous catheters. Provides continuous and intermittent measurements. Standalone diagnostic computer. Software-based signal processing for hemodynamic parameter derivation.

Indications for Use

Indicated for determination and monitoring of cardiopulmonary and circulatory variables in patients requiring hemodynamic assessment. No specific age or gender contraindications provided.

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2006

Pulsion Medical Systems c/o Dr. Jamie Sulley Triangulum Consulting Services, Inc. PO Box 99033 Raleigh, NC 27624

Re: K060898

> Trade Name: Pulsion Continuous Pulse Contour Cardiac Output (PiCCO Plus) System Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: June 29, 2006 Reccived: June 30, 2006

Dear Dr. Sulley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation enfitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .

Sincerely yours,

Bhimima for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT 4.0

## Indications for Use

510(k) Number (if known): _ K 06 Od 98

Device Name: PiCCO Plus

Indications for Use:

The PULSION PiCCO Plus is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO Plus measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered. the PiCCO Plus presents the derived parameters indexed to body surface area.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Plan 2/3)

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number

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(Posted November 13, 2003)